510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NOZClass II

Assay, 1,5-Anhydroglucitol (15ag)

21 CFR 864.7470 / Hematology
FDA source (opens on fda.gov)

NOZ is the FDA product code for Assay, 1,5-Anhydroglucitol (15ag), a class II device type, regulated under 21 CFR 864.7470. FDA's definition for this code reads: "The test provides quantitative measurement of 1,5-anhydroglucitol (15AG) in patient's blood. The test is for professional use, and is indicated for the monitoring of glycemic control in people with diabetes". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NOZ
Device name
Assay, 1,5-Anhydroglucitol (15ag)
FDA definition
The test provides quantitative measurement of 1,5-anhydroglucitol (15AG) in patient's blood. The test is for professional use, and is indicated for the monitoring of glycemic control in people with diabetes.
Regulation
21 CFR 864.7470
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code NOZ

By decision year
2 clearances under product code NOZ with a decision year between 2003 and 2018, 2003 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NOZ by decision year
YearClearances
20031
20181

Applicants with the most clearances

Product code NOZ
Applicants holding the most 510(k) clearances under product code NOZ
ApplicantClearances
Diazyme Laboratories, Inc.1
Tomen America, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code